Study Tagging Files

Study Tagging Files (STFs) offer clarity to an eCTD reviewer sifting through a submission’s clinical data by organizing it in a standardized, meaningful manner. STFs are akin to a table of contents or index in structure and purpose.

Communication between the sponsor and regulatory agency is often cited as the most important aspect of a regulatory submission. Properly labeled STFs simplify sponsor-agency dialogue by identifying the pieces of a submission that have already been received, and those that remain outstanding. STFs also help reviewers locate specific documents and provide consistency over the life cycle of a regulatory application.

Files associated with an STF are identified with a particular piece of metadata known as a file tag; which indicates the type of information contained in that document. An eCTD XML backbone itself does not contain enough information related to the subject matter of study reports and their related files – this additional information is provided in the STFs.

GlobalSubmit’s PUBLISH™ platform simplifies STF creation. Users simply drag and drop files into a study’s corresponding folder according to content type as they would any other section of an eCTD. PUBLISH then hides STF generation so that a user can focus on the next task. Keeping with the GlobalSubmit tradition of intuitive user features, PUBLISH prompts you to enter the required metadata such as duration, species, etc. only where it is required. This safeguard reduces the risk of experiencing validation errors associated with STF rules.

Best Practices

Each study must have a Study Tagging File (STF), even if it only includes a single document. Don’t underestimate the importance of an STF for a single document study – the information is still used to organize the document for review. It’s important to assign an accurate study number and a meaningful, concise title to each study (including nonclinical studies).

Study metadata is also used to organize studies. The metadata depends on the type of study (such as Single-Dose Toxicology) and may include: species, route of administration, duration, control type, or possibly no metadata at all. Remember to diligently QC your metadata, as eCTD contains no mechanism for updating incorrect metadata – and workarounds are cumbersome and confusing.

Each document in a study must be assigned a file tag identifying its contents. Make sure that you understand file tags and their usage. The tag “legacy-study-report” should be used for all clinical and nonclinical reports for which a single file is submitted.

For other regional submissions (especially EU) verify that your publishing tool will automatically remove the STF, and convert the metadata into appropriate node extensions to organize studies in place of the STF. If you publish EU submissions first, this process occurs in reverse.